REGISTRATION AND LICENSING OF HERBAL PRODUCTS IN KENYA

1. REGISTRATION AND LICENSING OF HERBAL PRODUCTS IN KENYA N. ELACHI ETHNOBOTANICAL R&D OFFICER-LAIKIPA WILDLIFE FORUM, OCTOBER 2013

2. REGISTRATION BODIES In Kenya, Herbal drugs are registered and licensed by the Pharmacy and Poisons board while food supplements are approved by KEBS.

3. Guidelines as per Pharmacy & Poisons Board (PPB) This guideline has been drawn to address the many issues on the quality of herbal and complementary medicines that have been used for a long period of time in Kenya. These issues include; • Misconception amongst herbalists that documentation requested for by PPB is intended to steal their indigenous knowledge and thus, there has been hesitation to submit applications. b) Lack of documented evidence on quality, safety & efficacy of Herbal and complementary products

4. Cont’d c) Unethical practices that include: • Adulteration of herbal and complementary products with conventional medicines • Advertising of Herbal and complementary products in print media, electronic and bill boards • Peddling of products with no therapeutic benefits • Unsubstantiated medicinal claims by herbal practitioners. • Dealing with herbal products whose toxicological profile is not known • Poor standards of preparation/manufacture and sale of herbal and complementary products

5. Submission of application An application for registration of herbal and complementary product shall include: • One duly filled application form and an electronic copy in MS Word on a CD-ROM including their supporting documents • Three (3) samples of the smallest commercial pack(s) from one batch with batch certificates of analysis. • An original Certificate of Pharmaceutical Product (WHO Format) on official papers of the issuing competent drug regulatory authority. • A site master file in case the product is manufactured at a plant(s) not inspected and approved by PPB. • Non refundable application fee for registration of medicines in Kenya and GMP inspection fees for facilities not yet inspected by PPB.

6. Payment of fee

7. Validity of Registration The registration of herbal and complementary products shall be valid for five (5) years unless earlier suspended or revoked by PPB or withdrawn by applicant. The Board gives reasons in writing when it suspends or revokes, or amends conditions of registration. Likewise the applicant shall also give reasons for terminating registration of a product

8. Particulars of the product • Product Name ;(trade or brand) name which is unique to a particular drug and by which it is generally identified.Theapplicant may provide evidence from Kenya Industrial Property Institute, KIPI, in regard to the requirements for registration of Trademarks. • Dosage form of the product ;the form in which the drug is presented – a macerate, infusions, ashes, decoctions, tablet, capsule, solution, suspension, emulsion, ointment, suppository etc. • Strength of the product shall be given per unit dosage form or per specified quantity: e.g. mg per tablet, mg per capsule, mg/ml, mg per 5ml spoonful, mg per g, etc. • Therapeutic use(s) ; the intended use should be only the major indication(s) the product may be multi-component with other pharmacological properties but the application should be restricted to the intended use.

9. Particulars of the product cont’d 5. Visual description of the product ; a full description/appearance of the herbal or complementary product including color, size, shape and other relevant features, e.g. green powder, brown liquid, pink film-coated tablets etc. 6. Type of container: The applicant should state the type of the primary package in which the herbal or complementary product is presented e.g. in HDPE bottles, Aluminum Sachets etc. 7. Pack size(s) ; the presentation of the product to be registered i.e. list all pack sizes

10. Cont’d 8. Proposed Shelf life (in months) shall mean the specified length of time prior to use for which a herbal or complementary product is deemed to remain fit for use under prescribed conditions supported by stability studies 9. Storage conditions: The proposed storage conditions should be indicated on the label and supported by stability studies 10. Country of origin;the country of manufacture or production, of the herbal or complementary product to be registered or country of product release.

11. PARTICULARS OF THE MANUFACTURER • Name of the Manufacturer ; the name, physical address, telephone number, fax number, and e-mail address of the site of manufacture shall be provided. • GMP status of the manufacturing site; If the new application is from a new manufacturing site, PPB will conduct inspection of the site or use other means to verify whether the facility complies with current Good Manufacturing Practices (cGMP) Regulations and/or guidelines.

12. COMPOSITION OF THE PRODUCT List all active ingredient(s) and all non active ingredient(s) used (i) Scientific or Botanical Name of the plant(s) e.g. Catharanthusroseus(Apocynaceae) (ii) The common name or synonym is the English name. Where not known the local vernacular name may be used e.g. Madagascar periwinkle (Catharanthusroseus), NeemTree (“Muarubaini” - Azandiractaindica) (iii) Part of Plant used: The part used should be specified e.g. leaf, root, bark, etc.

13. Cont’d (iv) Specification (USP, BP, or In house): The minimum range of specifications for the active ingredient(s) should be as given in recognized pharmacopoeias. Where the material is part of an established monograph then the material must comply with requirements of the monograph. Where the plant material is not subject to any established monograph the applicant must indicate in detail of all tests used to characterize the material with limits as relevant. (v) Quantity per dosage unit: The strength of the product shall be given per unit dosage form or per specified quantity: e.g. mg per tablet, mg per capsule, mg/ml, mg per 5ml spoonful, mg per g, etc. (vi) Chemical Constituent(s): For each of the active constituent(s) listed (e.g. Catharanthusroseus), indicate the major chemical compounds where known e.g. vincristine, or where not known major group of compounds e.g. indole alkaloids. (vii) Reason for inclusion: Where a material is included and is not the active ingredient indicate the purpose of its inclusion such as sugar as sweeter, honey as preservative

14. QUALITY CONTROL OF RAW MATERIALS • Botanical identification of the Plant used • Botanical name • Brief description of the living plant • Macroscopic identification • Microscopic identification

15. Cont’d b. Geographical source of the plant used c. Harvesting and collection of the plant d. Method of drying e. Storage and preservation of plant material f. Evaluation of plant materials-purity tests

16. Packaging and Labeling of the Finished Product (include package insert) The print size and color should be legible and in English or Kiswahili. The product label should have the following: a) Name of the product b) Composition: The quantitative list of main active ingredients including the common English name of the relevant plants. If the product is imported, plant name should be mentioned along with botanical name

17. Cont’d c) Dosage form d) Pack size e) Name of manufacturer and physical address of the manufacturing site f) Lot/Batch number g) Manufacture date and expiry date h) Storage conditions

18. PACKAGE INSERT This should contain the following information in English: a) Name and description of the product b) Composition: c) Pharmacological properties, where information is available d) Therapeutic indications e) Dosage: the minimum and maximum as well as average dosage levels, must be stated (if appropriate, specified for children and the elderly).

19. Cont’d f) Contraindications/precautions, Interactions and Cautions/warnings g) Withdrawals periods for veterinary herbal and complementary products h) Name and address of the manufacturer i) Overdose and treatment j) Adverse reactions k) Special considerations e.g. vaginal, rectal, and urethral preparations l) Storage conditions. m) Main vehicle/base

20. END!THANK YOU Nixon Elachi Desert Edge-LaikipiaWildlife Forum 0723729143